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Comparative Study
. 2020 Dec:133:104684.
doi: 10.1016/j.jcv.2020.104684. Epub 2020 Oct 29.

Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus

Gannon Ck Mak  1 , Stephen Sy Lau  2 , Kitty Ky Wong  2 , Nancy Ls Chow  2 , C S Lau  2 , Edman Tk Lam  2 , Rickjason Cw Chan  2 , Dominic Nc Tsang  2
Affiliations
Comparative Study

Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus

Gannon Ck Mak et al. J Clin Virol. 2020 Dec.

Abstract

Background: Numerous rapid antigen detection (RAD) kits for diagnosing COVID-19 patients are available in the market recently.

Objective: To compare analytical sensitivity and clinical sensitivity for the three commercially available RAD kits.

Study design: Analytical sensitivity for the detection of SARS-CoV-2 virus was determined by limit of detection (LOD) using RT-PCR as a reference method. Clinical sensitivity was evaluated by using respiratory specimens collected from confirmed COVID-19 patients.

Results: The LOD results showed that the three RAD kits varied from 102-105 fold less sensitive than RT-PCR. Clinical sensitivity of RAD kits ranged from 22.9 %-71.4 % for detecting specimens from COVID-19 patients.

Conclusions: Although RAD kits were less sensitive than RT-PCR, understanding the clinical characteristics of different RAD kits can guide us to obtain suitable specimens for testing. The likelihood of positive results for RAD kits will be higher.

Keywords: 2019 novel coronavirus; COVID-19; RT-PCR; Rapid antigen detection; SARS-CoV-2.

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Conflict of interest statement

None.

References

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